510(k) Report

Devices descending from K953877

572 later devices reach Mitek Gii Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company20133—
+8K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+8K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+9K261511Xpert AnkleNewclip Technics20260—
+9K260761APTUS Clavicle System 2.8Medartis AG20260—
+9K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+9K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+9K253538TeKBrace Knotless AnchorTheramicro20260—
+9K253695LigaMendRiverpoint Medical, LLC20260—
+9K254182AsterOsteonic Co., Ltd.20260—
+9K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+9K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+9K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+9K243469SignexOsteonic Co., Ltd.20250—
+9K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+9K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+9K243988RootMend MRRRiverpoint Medical, LLC20250—
+9K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+9K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+9K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+9K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+9K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+9K241539Activmotion SNewclip Technics20240—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+9K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+9K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+9K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+9K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+9K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+9K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+9K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+9K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+9K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+9K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd.20210—
+9K202307Activ FuseNewclip Technics20200—
+9K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+9K201149CoLink Plating SystemIn2bones USA, LLC20200—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+9K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+9K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+9K191972ARIX Wrist SystemJeil Medical Corporation20190—
+9K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+9K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+9K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+9K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+9K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+9K183331Parcus GFS BTBParcus Medical, LLC20193—
+9K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+9K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+9K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+9K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+9K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+9K160655OrthoButton CLRiverpoint Medical20169—
+9K152711Parcus GFS NakedParcus Medical, LLC20154—
+9K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+9K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+9K132502Variax 2 SystemStryker Trauma AG201321—
+9K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+10K254280F.A.S.T ScrewSteps Ortho20260—
+10K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+10K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+10K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+10K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+10K254215Arthrex Beaming SystemArthrex, Inc.20261—
+10K252246Leforte MMF SystemJeil Medical Corporation20260—
+10K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+10K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+10K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+10K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+10K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311